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临床试验/NCT03777709
NCT03777709已完成不适用

The FAITH! Trial: A mHealth Intervention to Improve Cardiovascular Health Among African-Americans

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2020年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Mayo Clinic
入组人数
85
试验地点
2
主要终点
Smoking Status Category

研究概览

简要总结

The purpose of this project is to apply a community-based participatory research (CBPR) approach to rigorously refine and test the feasibility and preliminary efficacy of an existing cardiovascular (CV) health and wellness digital application (app) prototype to improve CV health according to the American Heart Association Life's Simple 7 (LS7) framework among African-American (AA) adults within faith communities. The investigators hypothesize that the app-based intervention will be feasible and improve LS7 among AAs from baseline to 6-months post-intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • African American race/ethnicity
  • 18 years or older
  • Own a smart phone
  • Have basic Internet navigation skills
  • Have at least weekly Internet access (i.e. at home, church, or other public access)
  • Have an active email address
  • Intake of fruits/vegetables less than 5 servings a day
  • No engagement in regular physical activity
  • Able to engage in moderate physical activity
  • Exclusion criteria:
  • Unable to walk up 2 or more flights of stair or walk more than 1 city block without assistance or stopping
  • Pregnant (due to associated hormonal and weight changes)
  • Visual/hearing impairment or mental disability that would preclude independent app use

排除标准

  • 未提供

结局指标

主要结局

Smoking Status Category

时间窗: 6 Months post-intervention

Change in the categorical score (poor, intermediate, ideal) of the smoking status LS7 component from baseline to 6 months. Poor = Current Smoker, Intermediate = Former Smoker (\<1 year), Ideal = Never or Former (\>1 year).

Intervention Feasibility Measures - Participant Engagement With Tracking

时间窗: 6 months post-intervention

Participant engagement with weekly diet/physical activity tracking measured by number of times participant engaged with the tracking feature at 6 months post-intervention

Blood Pressure Change

时间窗: 6 months post-intervention

Change from baseline blood pressure at 6 month post-intervention. (average of 3 sitting readings of systolic and diastolic pressures)

Number of Participants With and Without Engagement With Sharing Board

时间窗: Immediate post-intervention

Participant engagement with sharing board measured by number of posts per month by each participant at immediate post-intervention

Fasting Glucose (Fingerstick)

时间窗: 6 months post-intervention

Change from baseline to 6 months post-intervention fasting glucose

Fasting Lipid Panel

时间窗: 6 months post-intervention

Change in fasting lipid panel from baseline to 6 months post-interventio

BMI

时间窗: 6 months post-intervention

Change from baseline BMI at 6 months post-intervention

Life's Simple 7 Composite Score Change

时间窗: 6 months post-intervention

Change from baseline Life's Simple 7 Composite Score at 6 month post-intervention The Life's Simple 7 Composite Score is adapted from the American Heart Association standards based on health assessment data and is a composite of each component (average BP from 3 readings, fasting lipid panel and glucose, height, weight, self-reported cigarette smoking status, dietary quality, and physical activity patterns). Point values are assigned to each component: 2 points for ideal, 1 point for intermediate, 0 points for poor. The total sum allows for a continuous measure of cardiovascular health ranging from poor to ideal (0-14 points). The final score will be categorized as 0-6 (poor), 7-8 (intermediate), 9-14 (ideal).

Intervention Feasibility Measures - Participant Engagement With Sharing Board

时间窗: Immediate post-intervention

Participant engagement with sharing board measured by the number of participants sharing at least one discussion board post during the intervention

Dietary Quality (According to American Heart Association Guidelines by the Validated, Culturally Appropriate, Delta Nutrition Intervention Food Frequency Questionnaire-FFQ)

时间窗: 6 months post-intervention

Dietary quality was measured using a checklist of foods and beverages, self-reported by participants at baseline and 6 months post-intervention. Responses range from never to 2 or more times per day (responses: never, \< once/month, once/month, 2-3 times/month, 1 time/week, 2 times/week, 3-4 times/week, 5-6 times/week, 1 time/day, 2 or more times/day). Nutrient intake was estimated via a computer software, multiplying reported food frequency by nutrient content, following by comparison to AHA guidelines. Healthy diet score include 5 components: 1. fruits and vegetables, ≥4.5 cups/d 2. fish, 2 or more 3.5-oz servings/wk 3. fiber-rich whole grains (≥1.1 g fiber/10 g carbohydrate), 3 or more 1-oz-equivalent servings/d 4. sodium, ≤1500 mg/d 5. sugar-sweetened beverages, ≤450 kcal/wk. Each component equals 1 point, resulting in scores from 0 to 5, which are categorized as Poor (0-1), Intermediate (2-3), or Ideal (4-5). Higher scores indicated better dietary quality.

Intervention Feasibility Measures - App Usability

时间窗: 6 months post-intervention

App usability assesses four domains (Impact, Perceived usefulness, Perceived ease of use, User control) using the Health Information Technology Usability Evaluation Scale (Health-ITUES) instrument. 20 items are assessed, each on a 5-point scale ranging from 1 (strongly disagree) to 5 (strongly agree). The overall Health-ITUES score was calculated as the mean of all 20 items, with each item being equally weighted. Possible total scores range from 1.0 (minimum) to 5.0 (maximum). A higher total sum indicates higher perceived usability of the technology measured at 6 months post-intervention.

Physical Activity Patterns (Minutes/Week of Moderate and Vigorous Intensity Physical Activity, Measured by the International Physical Activity Questionnaire-IPAQ)

时间窗: 6 months post-intervention

Change from baseline to 6 months post-intervention in the total minutes per week that a participant engaged in moderate and vigorous intensity physical activity.

Intervention Feasibility Measures - Participant Engagement With Modules

时间窗: Immediate post-intervention

App engagement as measured by the number of modules completed by the participants during the intervention. The number of participants who completed \<5 and ≥5 modules (out of 10) was calculated.

次要结局

  • Diet Social Support(6 months post-intervention)
  • Physical Activity Self-Efficacy(6 months post-intervention)
  • Psychosocial Measures - Religiosity/Spirituality(6 months post-intervention)
  • Psychosocial Measures - Optimism(6 months post-intervention)
  • Diet Self-Regulation(6 months post-intervention)
  • Physical Activity Social Support(6 months post-intervention)
  • Psychosocial Measures - Perceived Stress(6 months post-intervention)
  • Smoking at Baseline as Assessed by Cigarette Smoking Status(Day 1)
  • Diet Self-Efficacy(6 months post-intervention)
  • Physical Activity Self-Regulation(6 months post-intervention)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

LaPrincess C. Brewer

Associate Professor of Medicine

Mayo Clinic

研究点 (2)

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